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Sie suchen in allen Bereichen nach dem Autor Rehak E.
In der Rubrik Zeitschriften haben wir 2 Beiträge für Sie gefunden
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MerkenThe Pharmacovigilance System in the Russian Federation and EAEU
Rubrik: Ausland
(Treffer aus pharmind, Nr. 12, Seite 1426 (2022))
The Pharmacovigilance System in the Russian Federation and EAEU / Current Status and expected Changes · Rehak E1, Zamahaeva A2 · 1Edelgard Rehak RM Beteiligung GmbH, Storkow und Angelini Pharma Rus LLC, Moscow (Russia)
The Eurasian Economic Union (EAEU) is a regional economic union of former Soviet countries based on the Treaty on the Eurasian Economic Union signed on 29 th May 2014 coming into force on 1 st Jan 2015. EAEU member countries are – as of today – Belarus, Kazakhstan, and Russia as founding countries, and Armenia and Kyrgyzstan. The national pharmacovigilance system of the EAEU member states is harmonised within the Eurasian Economic Union and regulated mainly by EAEU resolution No. 87 of 3 rd Nov 2016 effective 6 th May 2017 [ 1 ]. The 2 n d edition of ...
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Marika Pečená, M.D.
MerkenLocal Bioequivalence Studies in Russia
Rubrik: Ausland
(Treffer aus pharmind, Nr. 09, Seite 1350 (2015))
Local Bioequivalence Studies in Russia / Pečená and Rehak • Bioequivalence Studies in Russia · Pe##269;ená M, Rehak E · 1Quinta Analytica, Prague (Czech Republic) und 2Edelgard Rehak Consulting, Storkow
Local clinical studies are a mandatory part of the registration process of all generic applications in the Russian Federation. Local expertise in bioequivalence studies rapidly evolves. The quality still needs to be substantially improved. Sponsors should pay high attention to selection and qualification of vendors in order to ensure a reliable and ethical conduct of the study.
